Possible Setback For Califf On Road To FDA

Rob Califf may have just run into his first serious roadblock on his path to become the FDA’s next commissioner. According to a report in the Boston Globe, Califf removed his name as a co-author from a series of papers, some of which were critical of current FDA policy.

Until now Califf’s nomination has not encountered a great deal of opposition. It is unknown whether this new development will create a serious obstacle to his nomination.

The new problem involves Califf’s role as a “driving force” and guest editor of the October issue of the journal Clinical Trials devoted to pragmatic clinical trials.

Califf has long been recognized as an authority on clinical trial design, and he has spoken frequently about the limitations of current trials and the need for innovation. The problem in this case appears to be that some of the ideas proposed in the papers run counter to current FDA rules. One potentially controversial idea is that informed consent may not be required from some patients in some trials.

According to the Globe, Califf “completed most of the series before he joined the FDA, remained as an editor of the publication but asked that his name be removed from the three articles he had co-written, according to other authors and the publisher of the series.”

One anonymous co-author told the Globe that “Califf had been told to mask his authorship by the FDA.” But an FDA spokeswoman told the Globe that Califf “requested that his name be removed as a coauthor from these three articles out of an abundance of caution to avoid any perception that he would be commenting as an FDA official through these articles.”

The Globe notes that removing an author’s name is unusual and that current guidelines state that “all authors receive the appropriate level of credit and responsibility.”

Rob Califf speaking last month at the European Society of Cardiology meeting in London

Rob Califf speaking  at the European Society of Cardiology meeting in London in September

 

 

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